Drug product
Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-25
D-1241-2019
Product summary
- Firm
- Akorn Inc
- Event
- Event 82657
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5,380 cartons (25 ampules per carton)
- Official record key
drug-enforcement:D-1241-2019
Official wording
Reason: Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing.
Code information: Lot #: 011198, Exp 01/22
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Potency or specification failure
Out of Specification